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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA261863 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep.
The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).
This study is a randomized controlled trial of young adult cancer survivors with clinically significant symptoms of insomnia to evaluate the cognitive-behavioral based Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).
All participants will take part in a single STEP-YA session, during which they will complete baseline measures prior to randomization and then receive the STEP-YA intervention. Participants will then be randomly assigned to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). Participants will also complete follow-up measures 4 and 8 weeks post-baseline.
It expected that about 74 people will take part in this study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NON-COACHING CONDITION STEP-YA | Active Comparator | Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. |
|
| COACHING CONDITION STEP-YA | Experimental | Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STEP-YA with Coaching | Behavioral | Online instruction on behavioral changes to improve sleep with 2 additional individually coached session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Change at 8 Weeks | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Baseline to 8-weeks post-intervention session |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Mood States Change at 8 Weeks | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity at 16 Weeks (Optional) | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | 16 weeks post-intervention session |
Inclusion Criteria:
To be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Recklitis, PhD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38019571 | Derived | Michaud AL, Bice B, Miklos E, McCormick K, Medeiros-Nancarrow C, Zhou ES, Recklitis CJ. Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial. JMIR Res Protoc. 2023 Nov 29;12:e52315. doi: 10.2196/52315. |
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The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | NON-COACHING CONDITION STEP-YA | Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. |
| FG001 | COACHING CONDITION STEP-YA | Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Session and Evaluation |
| |||||||||||||
| Required Follow-up |
| |||||||||||||
| Optional Follow-up |
|
From the original 56 participants who began the study and completed the Baseline questionnaire, one participant withdrew following the education session (reflected in the Participant Flow chart). That participant was not included in the analyzed sample reported here (n=55).
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| ID | Title | Description |
|---|---|---|
| BG000 | NON-COACHING CONDITION STEP-YA | Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Severity Change at 8 Weeks | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 8-weeks post-intervention session |
|
From enrollment to 8 weeks for all participants, and additional follow-up up to 16 weeks for participants who participated in the optional follow-up.
This was a minimal risk educational intervention. Participants self-report on significant health changes in their own words.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NON-COACHING CONDITION STEP-YA | Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Recklitis | Dana-Farber Cancer Institute | 617-632-5124 | crecklitis@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2023 | Jan 30, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| STEP-YA without Coaching | Behavioral | Online instruction on behavioral changes to improve sleep without additional individually coached session |
|
| Baseline to 8-weeks post-intervention session |
| Profile of Mood States Change at 4 Weeks | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment. | Baseline to 4-weeks post-intervention session |
| Insomnia Severity Change at 4 Weeks | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Baseline to 4-weeks post-intervention session |
| Initial Satisfaction With Intervention Session | Study specific questionnaire assessing intervention acceptability, credibility and participant satisfaction | Up to 4 weeks post-intervention |
| Satisfaction With Coaching Sessions | Study specific questionnaire describing satisfaction with coaching sessions | Up to 4 weeks post-intervention |
| Final Satisfaction With the Intervention | Study specific questionnaire asking about participant satisfaction with the intervention | 8 Weeks post-intervention session |
| NOT COMPLETED |
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| NOT COMPLETED |
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|
| COACHING CONDITION STEP-YA |
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Insomnia Severity Index | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Mean | Standard Deviation | Units on a scale |
|
| Profile of Mood States - Short Form (Total Mood Disturbance) | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Item responses are totaled to calculate scores on 7 subscales. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 higher scores indicating greater impairment. | Mean | Standard Deviation | Units on a scale |
|
| OG001 | COACHING CONDITION STEP-YA | Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. |
|
|
| Secondary | Profile of Mood States Change at 8 Weeks | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment. | One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 8-weeks post-intervention session |
|
|
|
| Secondary | Profile of Mood States Change at 4 Weeks | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment. | One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 4-weeks post-intervention session |
|
|
|
| Secondary | Insomnia Severity Change at 4 Weeks | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | One participant (Coaching Condition STEP-YA) withdrew following the education session. That participant was not included in the analyzed sample. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 4-weeks post-intervention session |
|
|
|
| Other Pre-specified | Insomnia Severity at 16 Weeks (Optional) | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Posted | Mean | Standard Deviation | Units on a scale | 16 weeks post-intervention session |
|
|
|
| Other Pre-specified | Initial Satisfaction With Intervention Session | Study specific questionnaire assessing intervention acceptability, credibility and participant satisfaction | Not Posted | Jul 2026 | Up to 4 weeks post-intervention | Participants |
| Other Pre-specified | Satisfaction With Coaching Sessions | Study specific questionnaire describing satisfaction with coaching sessions | Not Posted | Jul 2026 | Up to 4 weeks post-intervention | Participants |
| Other Pre-specified | Final Satisfaction With the Intervention | Study specific questionnaire asking about participant satisfaction with the intervention | Not Posted | Jul 2026 | 8 Weeks post-intervention session | Participants |
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | COACHING CONDITION STEP-YA | Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions. Participates will also complete follow up questionaires at 4 and 8 weeks post baseline. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D001523 |
| Mental Disorders |